During an inspection of your firm, located at 511 Creasman Drive, Winchester, Tennessee, on April 16-18, 20, and 23, 2012, an investigator from the U. S. Food and Drug Administration (FDA) determined your firm manufactures Blood Pressure Monitoring Computer Kiosks. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. You may find the specific regulations through links on FDA’s Internet home page at http://www.fda.gov.

Our inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)] as the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). We received a response from (b)(4) and E. Gregory Anspach, Vice President of Production, dated May 4, 2012, concerning our investigator’s observations noted on the April 23, 2012, FORM FDA 483 (FDA 483) issued to Mr. Anspach. The responses are addressed below in relation to each violation. The violations include, but are not limited to, the following:

For example, according to SOP006, Corrective and Preventive Action, (Rev. (b)(4)) Section 1.4, the quality management representative reviews all customer complaints according to the complaint file procedure outlined in SOP047, Complaint Files, (Rev.(b)(4)) to determine if a corrective action is required. However, SOP006 does not address the analysis of quality data or define the process of how quality data are analyzed. Your firm’s (b)(4) indicated complaint trending had fallen out of use at the facility.

We have reviewed your firm’s response and concluded it is not adequate. Your firm failed to provide details or documents defining a process for analyzing indicated quality data and to explain whether the existing CAPA procedure will be updated to include a process for initiating a CAPA based on such analysis. Further, your firm did not provide plans to retrospectively analyze existing quality data to determine whether a CAPA would be necessary for any existing issues or to analyze existing CAPAs to ensure appropriate statistical methodology were used during the analysis.

2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:

a. Your firm’s complaint handling procedure (SOP047 “Complaint Files” (Rev. (b)(4)) fails to define or refer to what constitutes a complaint. Further, Attachment A of the procedure indicates a complaint form must be completed when a complaint alleges injury, potential injury, hazard to safety, or death. However, the procedure does not indicate the actions needed to be taken for complaints involving other scenarios such as the failure of a device to meet its performance specifications, or intended use that did not involve an injury, potential injury, hazard to safety, or death.

b. A review of your firm’s service report summary for the month of March 2012 indicates multiple complaints were received for malfunctions such as: failure to read blood pressure; no power; inaccurate reading; and, cuff operations. These malfunctions were documented as part of service reports. However, complaint forms were not completed for these complaints. The complaint handling procedure does not address how complaints that do not involve an injury, potential injury, hazard to safety, or death should be processed.

We have reviewed your firm’s response and concluded it is not adequate. Your firm did not provide details or documents related to the implementation of a CAPA, nor was there evidence your firm considered systemic corrective action for this deficiency including retrospective review of existing complaints to ensure they were evaluated, as required.

3. Failure to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging, to meet any of its specifications unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c).

For example, the following complaint reports (identified by their device serial number) related to device failures, do not indicate an investigation was conducted to determine the cause of the failure nor do the reports refer to an investigation already performed:

We have reviewed your firm’s response and concluded it is not adequate. Your firm did not provide: details or documents related to the implementation of a CAPA; evidence your firm considered systemic corrective action for this deficiency to include conducting investigations on the above mentioned complaints; or, documentation explaining the reason why an investigation was not necessary. Furthermore, your firm did not provide evidence that a retrospective review of complaints was completed to ensure the complaints were investigated as required; nor, did your firm provide documentation explaining why such an investigation was not needed.

4. Failure to establish and maintain adequate procedures for finished device acceptance to ensure each production run, lot, or batch of finished devices meets acceptance criteria before being released for distribution, as required by 21 CFR 820.80(d). Specifically:

b. The Unit Traveler for the LC500 Blood Pressure Monitoring Computer Kiosk with serial number 500-001891 indicates the unit was shipped without verification and released by QA without the associated test data;

c. The Unit Traveler for the LC500 Blood Pressure Computer Kiosk with serial number 500-001868 indicates the unit was verified and released by QA without the associated test data; and,

We have reviewed your firm’s response and concluded it is not adequate. Your firm did not provide details or documents related to the implementation of a CAPA; nor was documentation provided indicating consideration of systemic corrective action for this deficiency. Further, your firm did not include a retrospective review of all Unit Travelers to ensure final acceptance activities were completed as required, nor was explanation provided as to why final acceptance activities were not completed.

5. Failure to establish and maintain adequate procedures to control all documents in accordance with 21 CFR Part 820, as required by 21 CFR 820.40. For example:

a. Document PRWI001, Rev. (b)(4), is entitled “Model LC300 Final Inspection and Test Instructions”. However, according to your firm’s “Master Index of Quality Documents” (QAF001, Rev. (b)(4)), document PRWI001, Rev. (b)(4), is entitled, (b)(4).” Further, according to Section 2.1 of the procedure entitled “Control of Documents” (SOP001, Rev. (b)(4)), controlled documents are, at a minimum, identified by issue date, revision level, and identification of the approving/issuing authority. However, this information was not noted on document PRWI001, Rev. (b)(4), “Model LC300 Final Inspection and Test Instructions.”

b. According to your firm’s “Master Index of Quality Documents,” (QAF001, Rev. (b)(4)), the most current version of document SVF004 “Customer Complaint Quality Assurance Inspection List” was April 25, 2011. The following complaints, identified by their device serial numbers, were observed recorded on older versions of the form:

We have reviewed your firm’s response and concluded it is not adequate. The response did not indicate your firm has plans to review all quality system records, including complaint records, to ensure the correct version of a form or document was used, and that older versions of the form are retained as required.

6. Failure to adequately analyze service reports with appropriate statistical methodology in accordance with 21 CFR 820.100, as required by 21 CFR 820.200(b). Specifically, your procedure entitled “Servicing” (SOP048, Rev. (b)(4)), fails to provide a process for analyzing service reports based on a defined statistical methodology to identify quality issues or trends.

We have reviewed your firm’s response and concluded it is not adequate. Your firm did not provide details or documents defining a process for trending and whether the existing servicing procedure would be updated. Further, your firm did not provide plans to retrospectively analyze existing service reports to ensure they do not represent quality issue trends requiring attention; and, your firm did not identify actions it would take when quality trends are identified.

Though not documented on the FDA 483, the following deficiency was noted:

• Failure to establish and maintain adequate requirements, including quality requirements, which must be met by suppliers, contractors, and consultants; and, failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results, as required by 21 CFR 820.50(a)(2). Specifically, your procedure entitled “Purchasing” (SOP010, Rev. (b)(4)), fails to provide a process defining the type and extent of control to be exercised over component suppliers requiring a second review due to the supplier being classified “(b)(4).”

Our inspection also revealed your devices are misbranded under Section 502(t)(2) of the Act [21 USC 352(t)(2)] as your firm failed to furnish material or information regarding the devices, as required by Section 519 of the Act [21 USC 360(i)] and 21 CFR 803 – Medical Device Reporting (MDR). Though not documented on the FDA 483, the following was discussed with firm management during the inspection:

Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17(a). For example, your firm’s Complaint Files procedure, SOP047 (issue date December 3, 2008), includes minimal MDR procedures, which are entitled Exhibit A. The following issues were noted:

• The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events which may be subject to MDR requirements. For example, there are no definitions of what is considered a reportable event under 21 CFR 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions, based on 21 CFR 803.3, of the terms: “become aware,” “caused or contributed,” “malfunction,” and “MDR reportable event;” as well as, definitions of the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 21 CFR 803.20(c)(1).

• The procedure does not establish internal systems which provide a standardized review process to determine when an event meets the criteria for reporting per 21 CFR 803. For example:

a. The procedure states the reporting of a complaint involving death or serious injury prompts the Quality Manager to report the event to FDA in accordance with 21 CFR 803. However, there are no instructions for conducting an investigation of each event and evaluating the cause of the event, as required by 21 CFR 803.50(b)(3).

b. The procedure does not specify who makes the decision for reporting events to FDA.

• Your MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:

a. Instructions for how to obtain and complete the FDA Form 3500A;b. Instructions for how you will submit all information reasonably known for each event;c. Circumstances under which you must submit initial, supplemental, or follow-up reports and the requirements for such reports; and,d. The address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.

Failure to have access to required information, the documents, and to include correct definitions of reportable events may result in failure of your firm to meet requirements under 21 CFR 803.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, or civil money penalties. Federal agencies are advised of the issuance of all Warning Letters regarding devices so they may take this information into account when considering the award of contracts. Additionally, premarket applications for Class III devices will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of any further corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 business days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this warning letter.

Your response should be sent to: Rebecca A. Asente, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact: Ms. Asente at (504) 832-1290, extension 1104.

Finally, this letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483, issued at the conclusion of the inspection, may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt action to correct the violations and to bring your products into compliance.